ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer

Inclusion criteria

• Male or female, aged 18 and 70 years, inclusive
• Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
• Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
• At least one uni-dimensionally measurable lesion according to the RECIST
• World Health Organisation (WHO) performance status (PS) of 0 or 1
• No previous chemotherapy for recurrent or metastatic disease
• Before subject registration a quality of life questionnaire should be completed

Exclusion criteria

• Previous chemotherapy for recurrent or metastatic disease
• Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
• Known severe hypersensitivity to ZD1839 or any of the excipients of this product
• Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
• Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
• Serum bilirubin greater than the upper limit of the reference range (ULRR)
• Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
• Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Pregnancy or breast feeding (women of child-bearing potential)
• Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded